Adverse drug reaction

BY Dr.A.Sridhar

• Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects

• “an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product”

WHO’s definition
“a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of

disease, or for modification of physiological function”

“Unexpected adverse reaction”
An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorisation, or expected from characteristics of the drug

• Toxicity Overdose of a drug that injures a physiologic system • Side effect Expected or predictable undesirable effect of a drug that occurs at therapeutic doses • Drug–drug interaction The presence of one drug effects the pharmacodynamics (absorption, distribution, metabolism, excretion) of another drug

• Drug–physiology interaction The presence of a drug alters the bodies physiology, leading to a harmful condition (may overlap with the concept of side effect)

• Drug–laboratory test Drug interaction will alter laboratory test results without impacting the physiologic system being measured— essentially a false-positive or false-negative laboratory test result • Allergic reaction  Drug triggers an immunologic response • Idiosyncratic reaction Drug creates a physiologic or psychological response that is unpredictable and is unique to the individual

Gell and Coombs Classification of Drug Hypersensitivity Reactions

Algorithm for the evaluation and management of drug reaction.

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